Recalls / —

—#69698

Product

Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V); REF 600-03-154.

FDA product code

KWQ — Appliance, Fixation, Spinal Intervertebral Body

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K031214, K040397

Affected lot / code info

All lots.

Why it was recalled

The screw locking cap may fracture when the surgeon rotates it into the locked position.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were notified via voicemail on 3/26/08 and a letter was sent to all distributors on 3/27/08 informing them that the plate should no longer be used and that all lots are being recalled. A letter dated 6/18/08 was issued to implant physicians recommending patient monitoring. Contact Zimmer Spine at 1-952-857-5636 for assistance.

Recalling firm

Firm

Zimmer Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.

Timeline

Recall initiated

2008-03-26

Posted by FDA

2008-09-01

Terminated

2009-11-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #69698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.